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Behavioral Intervention
Cognitive Training for HIV-Related Cognitive Impairment (TNT Trial)
Phase 2
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
TNT Trial Summary
This trial tests if a computerized cognitive training program can improve cognition in people with HIV-Associated Neurocognitive Disorder (HAND). It will focus on the two most impaired cognitive domains & measure changes in cognitive performance, executive functioning, and HAND severity.
Who is the study for?
This trial is for English-speaking adults over 40 with HIV-Associated Neurocognitive Disorder (HAND) who can meet in person and commit to a roughly 12-week program. It's not for those living far from the center, in unstable housing, or with conditions that affect cognition like significant brain trauma, recent COVID-19 infection, past cognitive training within three years, or severe neuromedical issues.Check my eligibility
What is being tested?
The study tests Targeted Neurocognitive Training (TNT) aimed at improving specific cognitive impairments in people with HAND. Participants are split into two groups: one receives TNT tailored to their most impaired cognitive areas; the other group does not receive any contact or intervention. The goal is to see if TNT can enhance overall cognition and executive functioning while reducing variability in cognitive performance.See study design
What are the potential side effects?
Since this intervention involves computerized cognitive training exercises rather than medication, traditional side effects are not expected. However, participants may experience fatigue or frustration during the tasks due to the challenging nature of the exercises designed to improve their cognitive function.
TNT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence Rates (after study data collection)
Attrition Rates (after study data collection)
Baseline Assessment of Cognitive Training
+2 moreSecondary outcome measures
BRACE+ (BrainBaseline Assessment of Cognition and Everyday Functioning)
TNT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Targeted Neurocognitive TrainingExperimental Treatment1 Intervention
BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on the two cognitive domains in which the participants exhibited the worst performance at baseline. Twenty hours or training will administer to each participant target these two cognitive domains (10 hours each). These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises.
Group II: No-Contact Control GroupActive Control1 Intervention
These participants will not receive any intervention.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,277,879 Total Patients Enrolled
16 Trials studying Aging
1,397 Patients Enrolled for Aging
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 40 years old or older.I do not have conditions affecting my thinking or senses, nor am I currently undergoing major treatments.I have undergone cognitive training in the last 3 years.I have been diagnosed with HAND.I am willing to attend in-person meetings.I live more than 60 miles away from the treatment center.
Research Study Groups:
This trial has the following groups:- Group 1: Targeted Neurocognitive Training
- Group 2: No-Contact Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Targeted Neurocognitive Training been given the official OK from the FDA?
"Though data has not yet been collected to support its efficacy, Targeted Neurocognitive Training is believed to be safe as it currently holds a score of 2 on the safety scale. This reflects that there are some studies indicating it's security."
Answered by AI
Are there any available slots still open for participants in this trial?
"Per the clinicaltrials.gov records, this medical study is not presently recruiting patients. Initially posted on August 1st 2023 and most recently updated on March 6th 2023, this trial has currently paused patient recruitment efforts. Despite that reality, rest assured as 1048 other studies are actively looking for participants right now."
Answered by AI
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